Comparison of the Efficacy and Safety of Mirogabalin and Duloxetine in Chemotherapy-induced Peripheral Neuropathy in a Randomized Controlled Trial: a Quality of Life Study in Cancer Survivors
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Keep this study
Lead
Pusan National University Yangsan Hospital
Age
19–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Cancer survivors aged 19 years or older.
Peripheral, symmetrical pain in both feet occurring within 12 weeks of initiating chemotherapy with taxane or platinum agents (or their combination).
Patients experiencing at least grade 2 peripheral neuropathy as defined by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, with an average pain intensity of 4 or higher on the Numerical Rating Scale (NRS) during the past week, following the completion of chemotherapy.
Concurrent use of selected analgesics (acetaminophen, nonsteroidal anti-inflammatory drugs \[NSAIDs\]) is permitted if the following conditions are met:
1. No new analgesics are introduced.
2. Current analgesics are not discontinued.
3. The total weekly 24-hour dose of analgesics does not vary by more than 10% during the 2 weeks prior to enrollment.
Ongoing treatment for peripheral neuropathy or neuropathic pain must be discontinued at least 7 days before randomization
You may not be if
Patients with a prior diagnosis of peripheral neuropathy due to diabetes, trauma, alcohol abuse, compression, or other causes, or those with a previously diagnosed central nervous system disorder. (Patients with pre-existing diabetes or thyroid disease who had no symptoms of peripheral neuropathy, such as numbness or tingling in the hands or feet, before chemotherapy may be included.)
Patients with significant psychiatric disorders, such as severe depression, bipolar disorder, or suicidal ideation.
Pregnant or breastfeeding patients.
Patients with a history of prior treatment with other neurotoxic chemotherapeutic agents.
Patients with renal impairment (creatinine clearance \< 30 mL/min) or hepatic dysfunction.
Patients with planned surgical procedures within 4 weeks of enrollment.
Clareo Health | Comparison of the Efficacy and Safety of Mirogabalin and Duloxetine in Chemotherapy-induced Peripheral Neuropathy in a Randomized Controlled Trial: a Quality of Life Study in Cancer Survivors
